MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 10 CEM; KNEE TIBIAL TRAY

Catalog Number	150670010
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).B3: date of event is an unknown date.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the tibia plate turned out to be punctured all the way into the implant.The sticker on the back of the box masks that it is a hole so it is missed when stored up on the shelf.When the staff opens it, the holes are seen all the way in.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided, "attached pictures of a tibia plate that turned out to be punctured all the way into the implant.The sticker on the back of the box masks that it is a hole so you miss it when you just put it up on the shelf.But when the staff would open it, you can see that there are holes all the way in according to the pictures." the device associated with this report was returned to depuy synthes for evaluation.Visual inspection confirmed the packaging was perforated in between both tyvek lids.The damage is consistent with an unknown spherical object puncturing both lids from the top and bottom of the inner and out lid, respectively.Furthermore, the package arrived for analysis in an opened state with both tyvek lids pealed away, therefore the origin of the damage is undetermined.The complaint product was forwarded to the manufacturer and the following observations were made during the manufacturing investigation.On examination of the returned complaint unit, it was found that there was a hole/perforation evident through synergy protector foam upwards and through the inner and outer tyvek.Although the carton and label was not perforated, some dent damage was identified.The part was not damaged.The contents of the packaging and parts were checked, no foreign object or sharp edges were identified.Similarly, the cone of the part was reviewed and was identified as not having any sharp edge that could have caused the failure mode.No evidence was found from review of the process/returned product that would point to potential cause of the hole.Therefore cause could not be traced to manufacturing.Due to the opened condition of the returned device, it cannot be established if the tyvek was puncture before or after the packaged was opened by the end user.A dimensional inspection for the device was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune fb tib base sz 10 cem would contribute to the complained device issue.However, compromised sterility could not be confirmed before the tyvek inner and outer lids were opened.Based on the information currently available, the potential cause is not established.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > 1) quantity manufactured: (b)(4).2) date of manufacture: 04/25/2023.3) any anomalies or deviations identified in dhr: none.4) expiry date: 03/31/2023.5) ifu reference: 090200828.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
What i can remember it was just the product in the picture whick was affected.I have no further information.Can it be verified how many devices are affected by this issue? "attached pictures of a tibia plate that turned out to be punctured all the way into the implant.".
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary attached pictures of a tibia plate that turned out to be punctured all the way into the implant.The sticker on the back of the box masks that it is a hole so you miss it when you just put it up on the shelf.But when the staff would open it, you can see that there are holes all the way in according to the pictures.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection was able to identify marks of damage in the inner part of the packaging.The package arrived opened.The complaint condition cannot be traced to manufacturing.The device was further sent to the manufacturer for investigation.Please refer to attachment "pc-001463962 manufacturing investigation".There is an impact on the sterility of the unit or integrity of the barrier.However there is no patient risk as the unit was not implanted.A dimensional inspection for the device was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune fb tib base sz 10 cem would contribute to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot 1) quantity manufactured: (b)(4).2) date of manufacture: 04/25/2023.3) any anomalies or deviations identified in dhr: none.4) expiry date: 03/31/2023.5) ifu reference: (b)(4).

• Brand Name: ATTUNE FB TIB BASE SZ 10 CEM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18021916
• Report Number: 1818910-2023-21849
• Device Sequence Number: 18040718
• Product Code: JWH
• UDI-Device Identifier: 10603295492122
• UDI-Public: 10603295492122
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K170806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150670010
• Device Lot Number: 4092648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 11/24/2023; 02/06/2024; 03/13/2024; 03/27/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/27/2023; 02/06/2024; 03/14/2024; 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FB INSRT SZ 9 8MM; ATTUNE CR FEM LT SZ 9 CEM; ATTUNE FB TIB BASE SZ 10 CEM; ATTUNE FB TIB BASE SZ 10 CEM; ATTUNE FB TIB BASE SZ 10 CEM
• Patient Sex: Unknown